To determine if the Trevo Retriever is as good or better than the Merci Retriever in restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a large vessel.
The TREVO 2 protocol was designed to assess the safety and effectiveness of the Trevo Retriever device and determine if it is substantially equivalent to the predicate Merci Retriever. The trial utilized a Primary Effectiveness Endpoint of revascularization and a composite Primary Safety Endpoint that included procedure-related serious adverse events occurring within 24 hours of the procedure. Subjects who presented to enrolling centers with large ischemic strokes were screened for eligibility in the study. If a subject met eligibility criteria, then Informed Consent was obtained prior to commencing the angiogram. If all inclusion/exclusion criteria were confirmed, including the angiographic criteria, then the subject was randomized.The Primary Effectiveness Endpoint was successful revascularization of the target occlusion, using the TICI score. Success was determined by the central Core Lab.The Primary Safety Endpoint is a composite endpoint, described in the protocol as the "Incidence of procedure-related serious adverse events (PRSAEs) through 24 hours post procedure (-6/+12 hours) defined as: vascular perforation or intramural arterial dissection, symptomatic ICH, embolization to a previously uninvolved territory, access site complication requiring surgical repair or blood transfusion, intra-procedural mortality, device failure (in vivo breakage), or any other complications judged by the Clinical Events Committee (CEC) to be related to the procedure."
- Mechanical Thrombectomy (Merci Retriever)Procedure
Intervention Desc: Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device. ARM 1: Kind: Experimental Label: Merci Retriever Description: Merci Retriever is the predicate product that received FDA clearance in 2004. Merci Retriever a first generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke. ARM 2: Kind: Experimental Label: Trevo Stentriever Description: Trevo Retriever is a second generation mechanical thrombectomy device intended to remove clot and restore blood flow in a neurovascular vessel in the setting of acute ischemic stroke. The Trevo Retriever is a type of stent, specifically design to allow for clot integration into the device. The clot in the retriever is then removed and blood flow is restored.
- Mechanical Embolectomy Procedure
Intervention Desc: Each arm will use either Merci or Trevo as the primary embolectomy device. ARM 1: Kind: Experimental Label: Merci Retriever ARM 2: Kind: Experimental Label: Trevo Stentriever
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Primary Efficacy Endpoint||acute/procedural||No|
|Primary||Primary Safety Endpoint||within 24 hours of procedure||Yes|
|Secondary||Secondary Endpoint||90 days||No|